FDA Orange Book · active-ingredient family
Dichlorphenamide
Dichlorphenamide is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DARANIDE · NDA 011366
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DARANIDERLD×2 | XERIS | NDA 011366 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DICHLORPHENAMIDE | RISING | ANDA 218783 | AB | Nov 18, 2025 | |
| ORMALVI | TORRENT | ANDA 215924 | AB | Dec 29, 2022 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Dichlorphenamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

